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Outpatient Total Joint Arthroplasty in Dedicated Daycare Facility vs Standard Patient Ward

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03896282
Recruitment Status : Active, not recruiting
First Posted : March 29, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Kirill Gromov, Hvidovre University Hospital

Tracking Information
First Submitted Date  ICMJE March 27, 2019
First Posted Date  ICMJE March 29, 2019
Last Update Posted Date April 2, 2019
Actual Study Start Date  ICMJE August 1, 2017
Actual Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
Patients discharged on day of surgery [ Time Frame: 12 hours ]
Success rate of discharge on day of surgery
Original Primary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
Patients discharged on day of surgery [ Time Frame: 12 hours ]
Succes rate of discharge on day of surgery
Change History Complete list of historical versions of study NCT03896282 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
  • Patient reported outcomes [ Time Frame: 3 months ]
    Total Oxford hip score (0-48, with 0 being worst and 48 best)
  • Readmissions [ Time Frame: 3 months ]
    Readmissions within 90 days
  • Patient reported outcomes [ Time Frame: 3 months ]
    Total Oxford knee score (0-48, with 0 being worst and 48 best)
  • reoperations [ Time Frame: 3 months ]
    reoperations within 90 days
Original Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
  • Patient reported outcomes [ Time Frame: 3 months ]
    Oxford hip score
  • Readmissions [ Time Frame: 3 months ]
    Readmissions within 90 days
  • Patient reported outcomes [ Time Frame: 3 months ]
    Oxford knee score
  • reoperations [ Time Frame: 3 months ]
    reoperations within 90 days
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Outpatient Total Joint Arthroplasty in Dedicated Daycare Facility vs Standard Patient Ward
Official Title  ICMJE Outpatient Total Joint Arthroplasty in Dedicated Daycare Facility vs Standard Patient Ward - a Randomized Controlled Trial
Brief Summary The purpose of this single center randomized controlled trial (RCT) is to investigate whether outpatient arthroplasty surgery in a dedicated daycare facility will improve discharge on day of surgery, as opposed to surgery followed by subsequent stay in the ward and also same day discharge, without compromizing safety and outcome.
Detailed Description

Introduction of fast-track total hip arthroplasty (THA) and total knee arthroplasty (TKA) has led to a decrease in length of stay without compromising patient safety and clinical outcome . In recent years outpatient THA and TKA has gained popularity, especially as major focus is placed on reducing cost and increasing efficiency in all medical treatments . Studies have shown outpatient arthroplasty to be feasible both for THA and TKA patients , with up to 70% of unselected patients being potentially eligible for outpatient surgery. Various results are published on success rate of discharged patients on the day of surgery, ranging from 25% to 99% , depending on patient selection and logistic setup. While the majority of published studies utilizes a modern fast-track setup with early mobilization and multimodal pain treatment, the optimal logistic setup remains unknown.

The purpose of this single center randomized controlled trial (RCT) is to investigate whether outpatient arthroplasty surgery in a dedicated daycare facility will improve discharge on day of surgery, as opposed to surgery followed by subsequent stay in the ward and also same day discharge, without compromizing safety and outcome.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Arthropathy of Knee
  • Arthropathy of Hip
Intervention  ICMJE Other: Mobilization at a dedicated daycare facility

All THA's are performed using a standard posterolateral approach with simple posterior soft-tissue repair. No infiltration anesthesia (LIA) is used in THA's. All TKA's are performed with a standard medial parapatellar approach without the use of tourniquet. Physiotherapy is started as soon as possible after surgery in the dedicated day care facility. Time till first mobilization is recorded as is total time mobilized supervised by a physiotherapist before discharge.

Patients are discharged if fulfilling the discharge criteria before 8 pm. Number of hours spent in hospital in total is recorded.

Study Arms  ICMJE
  • Active Comparator: daycare facility
    After surgery patient stay at daycare facility for mobilisation and stay until discharge or transfer to standard patient ward if nor discharged by 20.000
    Intervention: Other: Mobilization at a dedicated daycare facility
  • Active Comparator: standard patient ward
    After surgery patients are transferred to standard patient ward for mobilisation and stay until discharge.
    Intervention: Other: Mobilization at a dedicated daycare facility
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 28, 2019)
50
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Actual Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with clinical and radiological osteoarthritis of the hip suitable for primary cementless THA and patients with clinical and radiological osteoarthritis of the knee suitable for primary Cruciate Retaining (CR) TKA
  • Age 18-80
  • American Society of Anesthesiologists (ASA) Score (1-2)
  • BMI <35
  • Interested in and motivated for same day discharge
  • Family or relatives to be present for >24 hours after discharge
  • Able to understand and give consent to the study

Exclusion Criteria:

  • Unable to provide care at own home on day of surgery for >24 hours after discharge
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03896282
Other Study ID Numbers  ICMJE HVH-SDK141-RCT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Kirill Gromov, Hvidovre University Hospital
Study Sponsor  ICMJE Hvidovre University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hvidovre University Hospital
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP